Coeliac disease is an auto-immune disorder that affects 1% of the European population, in which the immune system can cause malabsorption and increases the risk of nutrient deficiencies, anaemia and osteoporosis, given that the obvious sources of gluten are a commonly-consumed range of food products.

Regulation (EC) No 1169/2011 prescribes a mandatory requirement for the supply of information on all foodstuff labels of substances known to cause allergic reactions and intolerances (including grains containing gluten) every time they are used as ingredients in food. Regulation (EC) No 41/2009 establishes EU harmonised conditions for the voluntary use of ‘gluten-free’ indications, without precluding the risk for people suffering from gluten intolerance.

Does the Commission consider that the only label indication on the presence of gluten, moreover in several foreign languages, may risk consumer confusion?

Does it consider it appropriate to establish harmonised conditions for the mandatory use of ‘gluten-free’ wording or the adoption of a clear and obvious European symbol indicating the absence of gluten?

Answer given by Mr Andriukaitis on behalf of the Commission – 6th April 2016

Regulation (EC) No 41/2009(1) lays down harmonised conditions that food business operators must respect to be able to use the ‘gluten-free’ and ‘very low gluten’ statements in the EU. Such harmonisation ensures the free movement of different foods appropriate to coeliacs’ needs and guarantees that such statements have the same meaning for all EU consumers.

To require operators to provide such statements on a mandatory basis would not be necessary to ensure consumer protection, given that Regulation (EU) No 1169/2011(2) requires, for all foods, the mandatory provision of information on the presence of substances known for their ability to trigger allergic reactions or intolerances (including cereals containing gluten and products thereof) whenever they are used in foods as an ingredient. In order to adequately inform consumers and avoid any confusion, Regulation (EU) No 1169/2011 requires that such information must be provided in a language easily understood by consumers in the Member States where the food is marketed and must be emphasised on food labels through a typeset that clearly distinguishes it from the rest of the list of ingredients.

The use of ‘gluten-free’ logos is not harmonised at EU level. The Commission has no information on the use of such logos at national level or whether their use positively influences consumer behaviour, for example by allowing consumers to identify gluten-free products more easily. For this reason, the Commission does not currently intend to harmonise the use of such logos in the EU.

The US Food and Drug Administration (FDA) is taking steps to reduce inorganic arsenic in infant rice cereal, a leading source of arsenic exposure in infants. Through a draft guidance to industry, the FDA is proposing a limit or “action level” of 100 parts per billion (ppb) for inorganic arsenic in infant rice cereal. FDA testing found that the majority of infant rice cereal currently on the market either meets, or is close to, the proposed action level.

This limit is parallel to the level set by the European Commission (EC) for rice intended for the production of food for infants and young children. (The EC standard concerns the rice itself; the FDA’s proposed guidance sets a draft level for inorganic arsenic in infant rice cereal.)

The proposed limit stems from extensive testing of rice and non-rice products, a 2016 FDA risk assessment that analyzed scientific studies showing an association between adverse pregnancy outcomes and neurological effects in early life with inorganic arsenic exposure, and an evaluation of the feasibility of reducing inorganic arsenic in infant rice cereal.